试验编号403：急性吸入毒性

OECD/OCDEYou are free to use this material subject to the terms and conditions available athttp://www.oecd.org/termsandconditions/Acute Inhalation ToxicityOECD Guidelines are periodically reviewed in the light of scientific progress, changingregulatory needs, and animal welfare considerations. Theoriginal acute inhalation Test Guideline 403 wasadopted in 1981. This revised Test Guideline 403 (TG 403) (1) has been designed to be more flexible, toreduce animal usage, and to fulfil regulatory needs.The revised TG 403 features two study types: aprotocol and a Concentration x Time (C x t) protocol.Primary features of this TestGuideline are the ability to provide a concentration-response relationship ranging from non-lethal to lethaloutcomes in order to derive a median lethal concentration (LC50), non-lethal threshold concentration (e.g.), and slope, and to identify possible sex susceptibility. The C x t protocol should be usedwhen thereis a specific regulatoryor scientificneed that calls for the testing of animals overmultiple time durations,such as for purposes of emergency response planning (e.g.derivingAcute Exposure Guideline Levels(AEGL),Emergency Response Planning Guidelines(ERPG), or Acute Exposure Threshold Levels(AETL)values),orforland-use planning.Guidance on the conduct and interpretation of TG 403 studies can be found in the GuidanceDocument on Acute Inhalation Toxicity Testing (GD 39) (2). The TG 403 should be conducted only as alast resort after all the existing information has been considered(including in vitro, in chemico, and insilico studies). If in vivo testing is required, consideration should be given to using alternative acuteinhalation studies that use fewer animals and more refined endpoints (TG 433 and TG 436).There areinstanceswhere the TG403may still be necessary or still required by some regulatory authorities. It shouldbe noted that data generated from the earlier versions of thisTestGuideline are equally valid.Definitions used in the context of this Guideline are provided in GD 39 (2).This Test Guideline enables test article characterization and quantitative risk assessment, andallows test articles to be ranked and classified according to the United Nations(UN) Globally HarmonizedSystem of Classification and Labelling of Chemicals (GHS) (3). GD 39 (2) provides guidance in theselection of the appropriate Test Guideline for acute testing. When information on classification andlabelling only is required, Test Guideline 436 (4) is generally recommended [see GD 39 (2)]. TestGuideline 403 is not specifically intended for the testing ofspecialized materials, such as poorly solubleisometric or fibrous materials ormanufactured nanomaterials.Before considering testing in accordance with this Test Guideline all available information onthe test article, including existing studies (e.g. TG 436)(4) whose data would support not doing additionaltesting should be considered by the testing laboratory in order to minimize animal usage. Information thatOECD GUIDELINE FOR THE TESTING OF CHEMICALS ©OECD, (2024)INTRODUCTIONTraditional LC50LC01INITIAL CONSIDERATIONS 1.2.3.4.5. OECD/OCDEmay assist in the selection of the most appropriate species, strain, sex, mode of exposure and appropriatetest concentrations include the identity, chemical structure, and physico-chemical propertiesof the testarticle; results of any in vitro or in vivo toxicity tests; anticipated uses and potential for human exposure;available (Q)SAR data and toxicological data on structurally related substances [see GD 39 (2)].Testing corrosive and/or irritatingtest articles at concentrations that are expected to cause severepain and/or distress should be avoided to the extent possible. The corrosive/irritating potential should beevaluated by expert judgment using such evidence as human and animal experience (e.g. from repeat dosestudies performed at non-corrosive/irritant concentrations), existing in vitro data (e.g. from TGs 430 (5),431 (6) or 435 (7)), pH values, information from similar substances or any other pertinent data, for thepurpose of investigating whether further testing can be waived. For specific regulatory needs (e.g. foremergency planning purposes), the TG 403 may be used for exposing animals to these materials becauseitprovides the study director or principal investigator with control over the selection of targetconcentrations. However, the targeted concentrations should not induce severe irritation/corrosive effects,yet sufficient to extend the concentration-response curve to levels that reach the regulatory and scientificobjective ofthe test. These concentrations should be selected on a case-by-case basis and justification forconcentration selection should be provided [see GD 39 (2)].This revised TG 403 has been designed to obtain sufficient information onthe acute toxicity ofa test article to enable its classification and to provide lethality data (e.g.LC50,both sexes as needed for quantitative risk assessments. Th